Advice - Extension of conditional inclusion procedure for ataluren (Translarna®)
The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to extend the conditional inclusion of ataluren (Translarna®) until 1 October 2024. This is an extension of 8 months. The Minister has adopted this advice. Ataluren is conditionally admitted to the basic health care package from 1 November 2021. The medicine can be used in the treatment of Duchenne's muscular dystrophy. This is a rare and progressive muscle disease. So far, 15 Dutch patients have been given access to ataluren through conditional inclusion.
Update October 2023: Conditional inclusion extended until 1 October 2024
The Minister has adopted this advice. This means that the conditional inclusion (CI) has been extended. The end date of the CI procedure has therefore been definitively changed from 1 February 2024 to 1 October 2024.
Read the decision in the Government Gazette.
Condition for which the medicinal product can be applied
Ataluren can be used for the treatment of Duchenne's muscular dystrophy due to a so-called nonsense mutation in the dystrophin gene, in ambulatory patients aged two years and older. So far, 15 Dutch patients have been given access to ataluren through conditional inclusion.
National Health Care Institute's advisory report on the extension of the conditional inclusion
As of 1 October 2023, the National Health Care Institute advises the Ministry of Health, Welfare and Sport to change the end date of the CI procedure for ataluren from 1 February 2024 to 1 October 2024. This is an extension of 8 months. The marketing authorisation holder must submit a reimbursement dossier to the National Health Care Institute, consisting of a pharmacotherapeutic dossier, a budget impact analysis and a pharmaco-economic evaluation, no later than 6 months after the CHMP advice. The National Health Care Institute will then have sufficient time to issue a package advice.